Fees and turnaround time for active ingredients
Here is the list of fees and turnaround times to help you with your active ingredients transactions.
Importer’s and wholesaler’s licence application
Application for a new licence
List of application fees for various licence types
Licence Type | Fee |
|---|---|
Importer's Licence (full scope) | $2,680 |
Importer's Licence (limited scope) for the following restricted activities:
| $400 |
Wholesaler's Licence | $2,680 |
Renewal fees
List of renewal fees for various licence types
Licence Type | Fee |
|---|---|
Importer's Licence (full scope) | $930 |
Importer's Licence (limited scope) for the following restricted activities:
| $220 |
Wholesaler's Licence | $930 |
Amendment fees
List of amendment fees for various licence types
Amendment | Fee |
|---|---|
Amend an importer's licence or wholesaler's licence with technical assessment | $2,250 |
Amend an importer's licence or wholesaler's licence without technical assessment | $400 |
Turnaround time (TAT)
TAT is 10 working days from the date of technical assessment completion or inspection close out.
For applications which do not require technical assessment or inspection, TAT is 10 working days from application date.
TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Licence validity
Licences are valid for 12 months from the date of licence approval unless otherwise stated. Applications for renewal of licences must be submitted and processed before the licence expiry.
Payment modes
GIRO (application form)
eNETS
Manufacturer’s licence application
Application for a new licence
List of application fees for various licence type
Manufacturer's Licence | Fee |
|---|---|
Manufacture of any active ingredient | $31,790 |
Primary (with or without secondary) packaging | $18,290 |
Secondary packaging only | $9,290 |
Renewal fees
List of renewal fees for various licence type
Manufacturer's Licence | Fee |
|---|---|
Manufacture of any active ingredient | $12,720 |
Primary (with or without secondary) packaging | $6,100 |
Secondary packaging only | $3,470 |
Amendment fees
List of amendment fees for various licence type
Manufacturer's Licence | Fee |
|---|---|
Manufacture of any active ingredient | $15,230 (With technical assessment) $450 (Without technical assessment) |
Primary or secondary packaging only | $8,720 (With technical assessment) $450 (Without technical assessment) |
Turnaround time (TAT)
TAT is 10 working days from the date of technical assessment completion or inspection close out.
For applications which do not require technical assessment or inspection, TAT is 10 working days from application date.
TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Licence validity
Licences are valid for 12 months from the date of licence approval unless otherwise stated. Applications for renewal of licences must be submitted and processed before the licence expiry.
Payment modes
GIRO (application form)
eNETS
Good Manufacturing Practice and Good Distribution Practice certificates
Fees
List of application fees for various certificate types
Application type | Fees |
|---|---|
Good Manufacturing Practice (GMP) certificate (with technical assessment) | $31,790 |
Good Manufacturing Practice (GMP) certificate (without technical assessment) | $220 |
Good Distribution Practice (GDP) certificate (with technical assessment) | $5,410 |
Good Distribution Practice (GDP) certificate (without technical assessment) | $220 |
Turnaround time (TAT)
TAT is 10 working days from the date of technical assessment completion or inspection closeout.
For applications which do not require technical assessment or inspection, TAT is 10 working days from application date.
TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Payment modes
GIRO (application form)
eNETS
Certificate of a Pharmaceutical Product
Fees
The application fee is $220.
Turnaround time (TAT)
TAT is 10 working days from application date.
TAT excludes the time taken for you to respond to our requests for clarification or additional information ("applicant's stop-clock").
Payment modes
GIRO (application form)
eNETS
